Study Type
Interventional - Procedure
completed
The UNIVERSAL study is a randomized, controlled trial to determine whether the use of ultrasound guidance for vascular access during coronary angiography or percutaneous coronary intervention (PCI) will reduce the rates of major vascular complications.
Patients who will undergo a coronary angiography or PCI using femoral access will be allocated to either:
- Femoral access using fluoroscopic and ultrasound guidance, or
- Femoral access using fluoroscopic guidance alone.
Primary endpoints:
- Incidence of major vascular complications [ Time Frame: up to 30 days post-procedure ]
- Femoral artery pseudonaneurysm
- Arteriovenous fistula
- Retroperitoneal bleed
- Major bleed based on BARC III criteria
- Hematoma with more than 5 cm of diameter.
Study Design
Parallel assignment, double masking RCT
NO. of Countries
1
NO. of Sites
1
NO. of Participants
496
Study Period
2018 - 2022
Sponsor
PHRI
Sanjit Jolly
Scientist
Sanjit Jolly
Scientist
Sanjit Jolly is an interventional cardiologist at Hamilton Health Sciences and associate professor at McMaster University. He has formal training in clinical trials with a M.Sc. in Health Research Methodology from McMaster. He was the principal investigator of the RIVAL trial, a randomized trial of 7021 patients comparing radial and femoral access for coronary intervention. He is also the principal investigator trial of the ongoing TOTAL trial, an international randomized trial (N=10,700) of thrombectomy during primary PCI.
Hamilton Health Sciences
Innovation Fund, Division of Cardiology, Department of Medicine, McMaster University (2018)
TCT 2023: Sanjit Jolly on UNIVERSAL trial: Routine ultrasonography guidance for femoral vascular access for cardiac procedures
CRT 2023: Sanjit Jolly on ultrasound-guided femoral access in patients with vascular closure devices: a prespecified analysis of UNIVERSAL
